BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLM A+ PLATINUM MODU

    MDR report key: 1852473 · Received September 30, 2010

    Report

    Report Number
    2921482-2010-00750
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 1, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING INCLUDING THE LOCKOUT SWITCH TEST AND KEYPAD TEST. THE CUSTOMER CONTACT INDICATED THE EVENT WAS A RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED & PRINTED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATES THAT ON (B)(6) 2010 AT 1038, LINE A WAS PROGRAMMED IN THE DOSE CALCULATION MODE, TO DELIVER A CONCENTRATION OF 8MG/1000ML, WITH A DOSE OF 15MCG/MIN, AT A CALCULATED RATE OF 113ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 950ML, FOR A DURATION OF 8HRS, 24 MINS & THE DELIVERY WAS STARTED. AT 1101, THE KEYPAD WAS LOCKED. AT 1102, THE POWER WAS SWITCHED TO AC. AT 1122, THE DEVICE ALARMED WITH N186 (DISTAL OCCLUSION) WHICH WAS NOT REPORTED BY THE CUSTOMER CONTACT & THE DELIVERIES STOPPED. BETWEEN 1122 & 1124, THERE WERE TWENTY-THREE N254 (HARD LOCKOUT ENABLED) ALARMS. AT 1124, THE DEVICE ALARMED WITH N253 (HARD LOCKOUT VIOLATION). BETWEEN 1124 & 1132, THERE WERE TWENTY N254 ALARMS. AT 1133, THE KEYPAD WAS UNLOCKED. AT 1138, THE DEVICE WAS TURNED OFF. THE DEVICE HISTORY INDICATED THAT THE PUMP CONTINUED TO BE IN USE AFTER THE REPORTED EVENT DATE OF (B)(6) 2010. ALL DATA PRIOR TO 0422 ON (B)(6) 2010 WAS OVERWRITTEN BY THE NEWER DATA; THEREFORE, THE PROGRAMMING FOR LINE B HAD BEEN OVERWRITTEN & WAS NOT AVAILABLE. A REVIEW OF THE SYSTEM OPERATORS MANUAL, INDICATES THAT "THE TOGGLE SWITCH, LOCATED BELOW THE AUDIO LEVEL CONTROL, ACTIVATES THE LOCKOUT FUNCTION WHEN THE LEVER IS PLACED IN THE "UP" POSITION, DISABLING ALL FRONT PANEL KEYS EXCEPT [STOP]." ADDITIONALLY, N254 (HARD LOCKOUT ENABLED) WILL OCCUR AFTER "PRESSING OF ANY KEY EXCEPT (STOP) DURING DELIVERY WHILE ANY ALARM IS ACTIVE AND LOCKOUT IS ENABLED." A N253 WILL OCCUR AFTER, "THE USE OF THE [STOP] KEY DURING DELIVERY WHILE ANY ALARM IS ACTIVE AND LOCKOUT IS ENABLED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR RESULTING IN THE PATIENT RECEIVING LESS MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, LINE A OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF NOREPINEPHRINE AT A RATE OF 113ML/HR. LINE B WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DOPAMINE AT A RATE OF 26ML/HR AND THE DELIVERIES WERE STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 1135, REPORTEDLY THE DEVICE ALARMED N254 (HARD LOCKOUT ENABLED). THE NURSE ATTEMPTED TO RESTART THE DELIVERY USING THE KEYPAD; HOWEVER, THE KEYPAD DID NOT RESPOND. THE PATIENT'S BLOOD PRESSURE (BP) DECREASED TO 59/39MMHG. THE PHYSICIAN WAS NOTIFIED. THE PATIENT WAS TREATED WITH AN UNSPECIFIED "SALINE BOLUS." THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THE CUSTOMER CONTACT STATED THE PATIENT'S BLOOD PRESSURE, "SLOWLY IMPROVED" WITH NO ILL LONG-TERM EFFECTS" AFTER THE THERAPIES WERE RESUMED. AFTER THE DEVICE WAS REMOVED FROM CLINICAL SERVICE WHILE STILL ALARMING, THE NURSE NOTED THE LOCKOUT SWITCH WAS IN THE "UPRIGHT POSITION" WHICH ACTIVATED THE KEYPAD LOCKOUT. IT WAS REPORTED THAT AFTER THE LOCKOUT SWITCH WAS TURNED TO THE OFF POSITION, THE ALARM STOPPED AND THE NURSE WAS ABLE TO USE THE KEYPAD TO TURN OFF THE PUMP. THE CUSTOMER CONTACT INDICATED THE EVENT WAS A RESULT OF AN OPERATOR ERROR. THE CUSTOMER CONTACT INDICATED THE NURSE DID NOT RECOGNIZE THAT THE N254 (HARD LOCKOUT ENABLED) ALARM CONDITION INDICATED THAT THE LOCKOUT SWITCH WAS ACTIVATED WHICH WOULD NOT ALLOW USE OF THE KEYPAD UNTIL THE SWITCH WAS TURNED TO THE OFF POSITION. DURING TESTING AT THE USER FACILITY, THE LOCKOUT SWITCH "WORKED PERFECTLY." THE CUSTOMER CONTACT INDICATED THAT THE USER FACILITY IS WORKING WITH THE STAFF TO COMPLETE THE YEARLY DEVICE CERTIFICATIONS, WHICH WOULD INCLUDE RECOGNITION OF THE N252 ALARM. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+ PLATINUM MODU 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening| R NOREPINEPHRINE| MANUFACTURER UNK| DOPAMINE| PLUM A+ SOFTWARE MODULE| LIST #12097| MANUFACTURER UNK| (B)(4)